Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

Posts tagged ‘generics’

In December, we started a series on new trends in the pharmaceutical industry and kicked off with a review of the growth in generics.

Today, we're going to take a look at the second big growth trend: emerging markets.

In a sense, one drives the other, because as you can see from the earlier post, the generics share has increased to over 70% and growing, while CAGR in developed countries for Pharma has flattened.  In order to drive or even maintain profit margins, manufacturers must therefore seek new opportunities elsewhere.  

This leads us to a new trend: the growth of emerging markets, particularly in the BRIC countries (Brazil, Russian, India and China).  Part of this is driven by demand as a burgeoning middle class emerges.  

Changing diet and lifestyle (usually more Westernised) also brings with it different medical conditions. For example, by 2025, a number of Pharma colleagues told me that they believe 50% of new patients in high growth therapeutic areas such as diabetes and oncology will come from BRIC.  That's an astonishing statistic and I'm not even sure it's feasible, but undoubtedly the number is on the rise.

Attractive market dynamics usually mean new market opportunities:

  • Fast growing economies with strong GDP growth – pharma market growth is strongly correlated with accelerating GDP growth 
  • Demographic changes 
  • Expansion of government healthcare coverage 
  • Increasing purchasing power of growing middle class 

The size of a blockbuster, however, is much lower than in developed markets: $25M in India and $100M in China, for example; but affordability is key to successful market access and ultimately, growth.

It isn't all plain sailing though, the markets may be both different and more complex:

  • Improving but challenging IP environment e.g. Patent enforcement 
  • Investment in local infrastructure required 
  • Differences in local regulatory/healthcare environment

India has the most challenging IP market, but Russia and Brazil are much more respectful and China has improved in leaps and bounds over the last 10 years.

The huge investment required to enter new markets essentially means that big Pharma with its considerable resources and a global infrastructure are more likely to compete than small Pharma and Biotech companies who may still be expanding their operations outside of their home market. 

Partnerships and joint ventures with local companies are one way forward for companies looking to expand overseas.  Sanofi-aventis just announced one such deal with Minsheng Pharmaceuticals in China, for example, while Pfizer also appear to be eyeing opportunities in China, according to a recent WSJ article.  It was interesting that Pfizer saw one key part of success was to develop good relationships with the government and healthcare providers in China:

"For instance, during the SARS crisis of 2003, Pfizer provided China with emergency supplies of anti-fungal drug Vfend, which was used to treat some secondary infections caused by the virus. That drug is now widely used around China despite not having a local patent."

In many ways, big Pharma companies with a strong generics arm may have an advantage, because the initial opportunity will be in marketing generic drugs and vaccines to the new markets.

GSK is focused on developing joint ventures in China to market its vaccines for MMR and flu.   Last June, a joint venture with Shenzhen Neptunus Interlong Bio-Technique Co. Ltd (Shenzhen Neptunus) was announced to market flu vaccines.  Then in October, a new joint venture was announced with the Jiangsu Walvax Biotech Company (Walvax) to develop and manufacture pediatric vaccines such as MMR.  Under the terms of this deal, GSK stated in the press release:

"Specifically, GSK will provide access to its proprietary adjuvant system which helps to improve efficiency and optimise production by increasing the number of vaccine doses that can be produced using a smaller amount of antigen.  Shenzhen Neptunus will provide additional local manufacturing capacity and R&D expertise.  Both companies will provide further investment in manufacturing."

Who are the big players in the emerging markets, you might well be wondering?  Me too, and a nifty chart in one of the sanofi-aventis analyst presentations provides the answer (I'm assuming the data came from IMS):

Picture 2
In many ways, this is the new frontier and the race is on to compete in emerging markets as they start opening up to big Pharma.  Interestingly, several of the above companies are strong in generics as well a branded pharmaceuticals.  

My pie in the sky prediction is that these emerging markets won't stay cheap for long though, they never do and no one wants to feel they live in a poor and developing nation.  The new emerging markets are vibrant and energetic, part of a new world order where the long term shifts and patterns are already changing.

Before closing, I'll leave you with an absolutely fascinating Ted talk from a Professor of Global Health who makes data sing, Dr Hans Rosling.  He is from the highly renowned Karolinska Institute in Sweden. He covers this concept with gusto and brings it to life – the emerging markets are stronger than many believe, while the old world order is much more fragile than it appears:

 

As Sting would say, "There is a deeper world than this, listen to me girl…."

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One of the books I am currently reading, when I am not frantically busy consulting on social media, new product development, competitive intelligence, strategic landscape opportunity assessments, disease overviews or even KOL market research studies, is “Negotiation Genius" by Deepak Malhotra and Max Bazerman of Harvard Business School.

They draw attention to the concept of “parasitic value creation” in the pharmaceutical industry and how this occurs when a pharmaceutical company pays a generics company to stay out of the market.  Despite the fact that the Federal Trade Commission (FTC) considers such deals illegal, there are numerous examples of this occurring.

How does it work?

Malhotra and Bazerman describe the scenario of a Pharma company with a drug earning $400M profit per year, where the introduction of a generic competitor will lower profit to $180M for the pharma company and generate $100M of profit for the generics company i.e. a combined profitability of $280M.  If the Pharma company pays the Generic company $125M to stay out of the market, both parties appear to win: the generics company receives more profit than it would have with competition and the Pharma company obtains profits of $400M less $125M i.e. $275M which is more than the $180M it would have received in competition with the generic.

It appears to be the perfect business solution on paper i.e. by working together the companies have maintained a $400M market rather than reduced it to a $280M one.  Anyone familiar with the prisoner’s dilemma in negotiating strategy will know that co-operation has the maximum payoff in game theory.

However, Malhotra and Bazerman ask the question where does the $120M in value that was “created” by co-operation come from ? The answer is that it is generated from the consumers who must now continue to pay more for the drug than they would if a generic was available.  They argue that there has been no value creation only a transfer of value from consumers to producers, therefore it is “parasitic value creation.”

The above might just be interesting negotiation theory were it not for the fact there are numerous apparent deals between generics companies and pharmaceutical companies where payments are made to delay the introduction of generics.  The FTC considers “pay for delay” agreements to be an unreasonable restraint of trade that attempts to monopolize the market, and has brought antitrust law suits against companies, with mixed success.

The idea of formally banning “pay to delay” agreements has been discussed as part of the current health care reform.  The FTC estimates that stopping this would save consumers $3.5B per year. 

Of the $35 billion in savings over ten years, $12 billion would be savings to the Federal government, not an insignificant amount.

It is hard to consider pharmaceutical companies as being “ethical” when parasitic value creation through “pay to delay” occurs, yet like baseball players with steroids, there is always going to be pressure to “cheat” if others are doing it and apparently getting away with it.  It will be interesting to watch the ongoing health care reform debate to see if "pay to delay" is addressed as part of it.

Do you believe these deals are fair game and ethical, or not?

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Earlier this year, we were deep into a consulting report on general trends in the Pharma industry and were struck by data in different yearly reports from PhRMA, the industry body in the US.  Basically, when we pieced the data together, it was clear that the market share of generics was not only growing but also likely to get worse in the next 2-3 years with major expiries expected.

Take a look at this chart we put together from PhRMA reports:

Picture 63
In the last 8 years, the share of generics has increased by an amazing 21% and the future growth may well increase to 9-10% per annum in the near term.

We were therefore not in the slightest bit surprised to read this report in The Economist last month predicting that a huge drop in branded sales revenues is to be expected in 2011, which is very much in line with our own analysis and predictions:

Picture 61 In case you're wondering what's happening in 2011, think blockbusters such as Lipitor, Plavix, Seroquel and Zyprexa to name a few and some of those will experience patent challenges before then.  Interestingly, between 2009 and 2011 Pfizer (Lipitor), Lilly (Gemzar and Zyprexa) and sanofi-aventis (Eloxatin, Taxotere and Plavix) will all see major losses in revenues due to patent erosion as they scramble to make up for the losses with various approaches.

In addition on the oncology front, Taxotere, Doxil and Gemzar are all due to expire next year, so the biggest impact in overall revenues will likely be seen in 2011 when multiple generic entries will further drive the price down significantly.

It's no wonder, then, that Pharma and Biotech companies are starting to rethink their future strategies given the dearth of new products coming through the pipeline at a rate that isn't fast enough to replace the blockbusters going generic. 

What options are out there that can be considered?

a) License late stage or 'hot' products from smaller pharma or biotech companies at a premium.  Many oncology companies are racing to do this such as J&J with abiraterone, Astellas with Medivation and Celgene with romidepsin, for example.

b) Creative life cycle management such as new formulations, branded generics or own-label medications (eg Novartis has successfully tried combinations of these with Voltaren, Sandogobulin and lactulose)

c) Expand into generics in emerging countries such as China, Brazil, Russia and Asia where their is a rapidly growing middle class demand for new medicines to treat lifestyle and aging diseases (eg sanofi-aventis, Pfizer, Novartis, Merck and GSK)

d) Consolidate therapy areas and have a narrower focus with increased licensing ties or acquisitions in specialty areas of interest (eg BMS, Genentech)

e) Greater focus on rarer diseases with a strong focus on rationale drug design and efficacy, leading to higher per patient prices (eg Genzyme, Novartis, Allos Therapeutics)

The recent round of mergers is unlikely to be the last for a while as others are already happening or being worked on.  The rate of licensing deals has begun to pick up significantly lately, driving up the asking price in the process, as Biogen IDEC found recently when Facet Biotech tartly declined their $17.50/share offer for the company.

Overall, I think the general trend for utilising more creative strategies with generics, emerging markets and better life cycle management strategies are here to stay.  There will always be new products coming onto the US market, but with an increasing focus by the Obama Government on pharmacoeconomics and cost effectiveness of new medicines, the Pharma industry must either innovate, diversify or struggle as patent expiries focus everyone's attention on the bottom line.  

It will be interesting to see who comes out stronger and better positioned for the future and who dies.  The difference between winning and losing is sometimes very small, as Vion found this year with Onrigin. Others may well follow suit and seek bankruptcy protection in 2010 if their Russian Roulette strategy doesn't come up trumps.

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